Quality Assurance Operational Specialist

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About the Job:

Job Responsibilities:

• Deviation Investigations:

  • All deviations in the process or specifications that can affect product quality are investigated to evaluate the root cause, corrective actions and preventive measures needed to prevent re-occurrence.

  • Ensure of non-recurrence of repeated deviations.

• Shopfloor Activities:

  • Review of the batch records before release to the market.

  • Manage batch record archiving

  • Performing quality tours in each manufacturing GMP area.

  • Maintain compliance to local and Sanofi regulations in manufacturing areas.

  • Execution APR plan execution

  • Manage Quality culture program of the site.

  • Monitor Data integrity program of the site.

  • Monitor deviations impacted non-sterile areas.

• Finished goods disposition. -

  • Collecting data daily from the various departments concerned i.e. production, packaging, &     Q.C

  • Checking and reviewing the data to ensure its adherence to specified protocol & therefore, according to Sanofi   Directives & Guidelines & current GMP, on daily basis.  

  • Checking the finished goods retain samples.

  • Following up corrections with the concerned person in the respective department.

  • Summarizing data from protocols through documenting them in standard checklist& batch release.

  • Archiving of batch records with its concerned attachments up to 10 years.          

  • Delegated by QA manager for finished products release/reject activities for non-sterile / sterile batches.

• Quality tours

  • Perform routine Quality tours in the responsible areas.

  • Perform GEMBA & process observation within the responsible areas.

• HSE Responsibilities:

  • Ensures HSE approval on any SOP that requires certain HSE precautions.

  • Ensures HSE approval on any change.

  • Commitment to the appropriate PPE use.

  • Follow the approved HSE policy and requirements.

  • Following the statutory legislation concerning Health, Safety and environmental law.

  • Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

JOB-HOLDER’s ENTRY REQUIREMENTS:

• Bachelor’s degree in pharmaceutical science

• 3-5 years of related experience

• Shop floor activities.

• QA Documentation and compliance systems experience.

• Expert in Pharmaceutical industry & raw materials “API & Non-API”

• Decision making & problem solving.

• Deviation management

• Risk management & Root cause analysis tools.